دراسة تأثير الكهرباء الساكنة على الجرعة المتحررة من شكل إرذاذي معاير الجرعة
Abstract
تم إجراء دراسة تأثير الكهرباء الساكنة المتولدة في الحاضنة (actuator) جراء طريقة التجفيف على محتوى الجرعة المتحررة من عبوة شكل إرذاذي في حالتين :
ü غسل الحاضنة وتجفيفها باستخدام قطعة قماش.
ü غسل الحاضنة وتركها تجف في الهواء فقط.
أًجريت الدراسة على شكل إرذاذي معاير الجرعة (metered dose inhaler) لكبريتات السالبوتامول من إنتاج شركة صناعة دوائية محلية.
أظهرت النتائج أهمية طريقة تجفيف الحاضنة على محتوى الجرعة المحررة من المادة الفعالة، حيث إن محتوى الجرعات المحررة من عبوة الشكل الإرذاذي بعد غسل الحاضنة وتجفيفها باستخدام قطعة قماش لا تحقق المتطلبات الدستورية، و تقع خارج المجال المسموح به دستورياً (75-125%)، بينما محتوى الجرعات المتحررة بعد غسل الحاضنة، و تركها تجف وحدها تحقق المتطلبات الدستورية، و تقع ضمن المجال المقبول.
يعزى اختلاف النتائج بين محتوى الجرعات في الحالتين السابقتين إلى الكهرباء الساكنة المتولدة في الحاضنة جراء عملية التجفيف.
A study of the effect of electrostatic charge that is generated in actuator due to drying methods on the delivered dose of metered dose inhaler has been done in tow cases:
ü Washing actuator and drying it by a clothe.
ü Washing actuator and let it dry alone.
A study has been done on metered dose inhaler containing salbutmaol sulfate and manufactured by a local company.
The results show the importance of drying methods on the delivered dose. The delivered doses of metered dose inhaler after washing the actuator and dry it by a clothe hadn't been achieved the USP-34 requirements (out of range 75-125%), while the delivered doses after washing actuator and let it dry alone had been achieved the USP-34 requirements.
The difference in results between the two cases belong to electrostatic charge generated in actuator due to drying methods.
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